Palifermin for the Reduction of Oral Mucositis in Patients With Locally Advanced Head and Neck Cancer

NCT ID: NCT00101582

Last Updated: 2016-09-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 188 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-08-31
• Study Completion Date: 2016-08-31

Brief Summary

The purpose of this research study is to test the safety and effectiveness of palifermin to determine if weekly doses can be safely administered to reduce the incidence (occurrence of), duration (length of time) and severity (amount of pain) of oral mucositis (painful sores in the mouth). Mucositis is a common side effect for patients receiving chemotherapy (cancer-killing drug) and radiotherapy (cancer-killing x-rays) for the treatment of head and neck cancer (HNC).

Detailed Description

This study consisted of 2 phases. The acute oral mucositis (OM) evaluation phase includes the time from randomization to the time of severe OM (WHO Grade 3 or 4) resolution (up to Week 12 or up to Week 15 for participants whose severe OM is not resolved at Week 12). In the acute OM evaluation phase, participants were randomized to receive either a single IV dose of palifermin or placebo at 180 μg/kg, 3 days before the start of radiotherapy, plus 7 once-weekly palifermin or placebo doses at the same dose level during a 7-week radio/chemotherapy course. In the long-term follow up phase, participants are followed until death, withdrawal of consent, or loss to follow-up. The long-term follow up phase is still ongoing.

Conditions

Mucositis; Solid Tumors; Stomatitis; Head and Neck Cancer; Squamous Cell Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Palifermin

Participants received a single intravenous dose of palifermin at 180 μg/kg three days before the start of radiotherapy, and then 7 once weekly palifermin doses at the same dose level during a 7-week radiotherapy/chemotherapy course.

Group Type: EXPERIMENTAL

palifermin

Intervention Type: DRUG

cisplatin chemotherapy

Intervention Type: DRUG

Commercially available cisplatin was administered as an intravenous infusion at a dose of 100 mg/m\^2 on Days 1, 22, and 43.

Radiotherapy

Intervention Type: RADIATION

Radiotherapy was delivered in 200 cGy daily fractions, 5 days a week.

Placebo

Participants received a single IV dose of placebo three days before the start of radiotherapy, and then 7 once weekly placebo doses during a 7-week radiotherapy/chemotherapy course.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

cisplatin chemotherapy

Intervention Type: DRUG

Commercially available cisplatin was administered as an intravenous infusion at a dose of 100 mg/m\^2 on Days 1, 22, and 43.

Radiotherapy

Intervention Type: RADIATION

Radiotherapy was delivered in 200 cGy daily fractions, 5 days a week.

Interventions

Placebo

Intervention Type: DRUG

palifermin

Intervention Type: DRUG

cisplatin chemotherapy

Commercially available cisplatin was administered as an intravenous infusion at a dose of 100 mg/m\^2 on Days 1, 22, and 43.

Intervention Type: DRUG

Radiotherapy

Radiotherapy was delivered in 200 cGy daily fractions, 5 days a week.

Intervention Type: RADIATION

Other Intervention Names

Kepivance; Recombinant Human Keratinocyte Growth Factor (rHuKGF)

Eligibility Criteria

Inclusion Criteria

• Histologically documented squamous cell carcinoma involving either the oral cavity, oropharynx, nasopharynx, hypopharynx, or larynx
• Newly diagnosed, locally advanced stage head and neck cancer (unresectable/unresected disease); American Joint Committee on Cancer [AJCC] Stage III, IVA or IVB amenable to radiotherapy with concurrent chemotherapy as the definitive treatment modality
• At least 50 Gray of radiation treatment to areas of the oral cavity/oropharynx mucosa that can be visualized
• Concurrent chemotherapy regimen of Cisplatin 100mg/m^2 on days 1, 22, and 43
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) less than or equal to 2
• Adequate hematologic, renal and hepatic function
• Negative pregnancy test by serum or urine
• Signed informed consent

Exclusion Criteria

• Presence or history of any other primary malignancy (other than curatively treated in situ cervical cancer, or basal cell carcinoma of the skin without evidence of disease for greater than 3 years)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amgen

INDUSTRY

Sponsor Role: collaborator

Swedish Orphan Biovitrum

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MD

Role: STUDY_DIRECTOR

Amgen

Other Identifiers

20020402

Identifier Type: -

Identifier Source: org_study_id

NCT00963456

Identifier Type: -

Identifier Source: nct_alias